Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000940
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected With HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Trial to Evaluate the Safety and Efficacy of Induction Treatment With Lamivudine Plus Stavudine Plus Abacavir Plus AmprenavirRitonavir Followed by Supervised Treatment Interruption in Subjects With Acute HIV Infection or Recent Seroconversion
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine what effect taking a combination of five anti-HIV drugs during the early stage of HIV infection then temporarily stopping them once or twice may have on the amount of HIV virus in the blood viral load The study will also evaluate the safety and effectiveness of this anti-HIV drug combination
Detailed Description:
Acute primary HIV infection represents a potentially unique opportunity to eradicate the infection Although plasma viral load rises rapidly the dominant infecting virus is relatively uniform genetically and infection may not be fully established in all tissue sites until some time after exposure Current antiretroviral therapy is able to reduce plasma viral load to unmeasurable levels in established infection However there are many questions that remain about the treatment of primary HIV infection While it is assumed that aggressive antiretroviral regimens are required it is not known how long they must be continued It is hoped that after an interval of aggressive therapy the number of agents could be safely reduced This study evaluates if viral suppression can be sustained after study therapy is withdrawn
Participants in this study will receive lamivudine 3TC stavudine d4T abacavir ABC amprenavir APV and ritonavir RTV for at least 52 weeks During this induction phase participants will be followed through regular study visits every 4 or 8 weeks If the participants viral load and CD4 counts are within study parameters at the end of 52 weeks the participant will discontinue all antiretroviral medications simultaneously Participants in the treatment interruption phase will be followed weekly initially every 2 weeks for 8 weeks and then every 4 or 8 weeks Treatment may be restarted if necessary during this phase based on viral load and CD4 counts If treatment is restarted the participant will receive 3TC d4T APV and RTV but not ABC During this reinduction phase participants will be followed every 4 or 8 weeks
Depending on viral load and CD4 counts participants may be eligible for a second treatment interruption phase following the reinduction phase Participants will once again stop all antiretroviral medications simultaneously and will have the same monitoring as in the first treatment interruption phase Following this second treatment interruption participants will be restarted on 3TC d4T APV and RTV and will be evaluated at Weeks 4 8 16 and 24 at which time participants go off study
The length of study participation for individual participants will vary The length of each phase will be highly dependent on the participants laboratory parameters In general participants will be enrolled in the study for 3 to 4 years Participants may also enroll in immunology compartment pharmacology and medication compliance substudies
Participants in this study will receive lamivudine 3TC stavudine d4T abacavir ABC amprenavir APV and ritonavir RTV for at least 52 weeks During this induction phase participants will be followed through regular study visits every 4 or 8 weeks If the participants viral load and CD4 counts are within study parameters at the end of 52 weeks the participant will discontinue all antiretroviral medications simultaneously Participants in the treatment interruption phase will be followed weekly initially every 2 weeks for 8 weeks and then every 4 or 8 weeks Treatment may be restarted if necessary during this phase based on viral load and CD4 counts If treatment is restarted the participant will receive 3TC d4T APV and RTV but not ABC During this reinduction phase participants will be followed every 4 or 8 weeks
Depending on viral load and CD4 counts participants may be eligible for a second treatment interruption phase following the reinduction phase Participants will once again stop all antiretroviral medications simultaneously and will have the same monitoring as in the first treatment interruption phase Following this second treatment interruption participants will be restarted on 3TC d4T APV and RTV and will be evaluated at Weeks 4 8 16 and 24 at which time participants go off study
The length of study participation for individual participants will vary The length of each phase will be highly dependent on the participants laboratory parameters In general participants will be enrolled in the study for 3 to 4 years Participants may also enroll in immunology compartment pharmacology and medication compliance substudies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AACTG 371 | Registry Identifier | DAIDS ES | None |
| 10099 | REGISTRY | None | None |
| ACTG 710 substudy | None | None | None |
| ACTG 711 substudy | None | None | None |
| ACTG 729 substudy | None | None | None |
| ACTG 709 substudy | None | None | None |